NCT01777035

Brief Summary

To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

10.5 years

First QC Date

January 16, 2013

Last Update Submit

February 17, 2022

Conditions

Respiratory Failure

Keywords

mechanical ventilationphysical therapyoccupational therapyICU acquired weaknesscritical illness myopathy

Outcome Measures

Primary Outcomes (2)

  • presence of cognitive impairment

    within the first 30 days after ICU admission

  • presence of cognitive impairment

    up to 1 year post discharge

Secondary Outcomes (3)

  • cognitive test score

    up to 1 year post discharge

  • institution free days

    up to 1 yr post discharge

  • Insulin Resistance

    day 3 of mechanical ventilation

Study Arms (2)

Early physical therapy(PT) occupational therapy (OT)

EXPERIMENTAL

Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption

Other: early PT OT

standard care

NO INTERVENTION

PT OT delivered as ordered by the primary ICU team

Interventions

early PT OTOTHER

1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption. 2. active assisted ROM in supine position. 3. treatment is advanced to bed mobility activities 4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. 5. progression to transfer training, and finally pre-gait training and ambulation. 6. progression of activities dependent on patient tolerance and stability 7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.

Early physical therapy(PT) occupational therapy (OT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intubated and MV \> 24, \< 96 hours
  • Baseline Barthel Index Functional Score \> 70, functional at home

You may not qualify if:

  • Rapidly changing neurological conditions (e.g. stroke)
  • Cardiac arrest as cause for respiratory failure
  • Elevated intracranial pressure
  • Pregnancy (due to inability to provide continuous fetal monitoring)
  • Terminal condition (life expectancy \< 6 months)
  • Traumatic brain injury, multiple limb fractures, pelvic fractures,
  • Severe chronic pain syndrome on admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (2)

  • Patel BK, Wolfe KS, Patel SB, Dugan KC, Esbrook CL, Pawlik AJ, Stulberg M, Kemple C, Teele M, Zeleny E, Hedeker D, Pohlman AS, Arora VM, Hall JB, Kress JP. Effect of early mobilisation on long-term cognitive impairment in critical illness in the USA: a randomised controlled trial. Lancet Respir Med. 2023 Jun;11(6):563-572. doi: 10.1016/S2213-2600(22)00489-1. Epub 2023 Jan 21.

    PMID: 36693400DERIVED

  • Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.

    PMID: 30217640DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • John P Kress, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 28, 2013

Study Start

July 19, 2011

Primary Completion

January 14, 2022

Study Completion

January 14, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations

US(1)